According to Emergo consultants in São Paulo, Brazil’s medical device market regulator ANVISA will issue a 60-day consultation for a proposal to change the agency’s cadastro registration pathway for Class I devices to a notification pathway, with implications for premarket review requirements for affected manufacturers.

Current ANVISA cadastro registration requirements

Under ANVISA’s existing requirements for cadastro registration, lower-risk device manufacturers must submit applications and legal documentation to the regulator for premarket review, as well as provide their Brazil Registration Holders (BRH) with technical dossiers, label and indications for use documentation in case of ANVISA audits.

Once ANVISA publishes its public consultation on the proposed notification pathway for low-risk devices, Emergo consultants will provide further analysis regarding changes to premarket submission requirements.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.